CA1262680A

CA1262680A - Absorptive pads and method of making

Info

Publication number: CA1262680A
Application number: CA000504611A
Authority: CA
Inventors: Edward H. Kass
Original assignee: Harvard College
Current assignee: Harvard College
Priority date: 1985-03-20
Filing date: 1986-03-20
Publication date: 1989-11-07
Also published as: MX166867B; IL78207A; EP0224494A1; DK165900B; GR860744B; ES8800835A1; EP0224494A4; IN168051B; WO1986005388A1; BR8606551A; CN1009425B; CN86102652A; DK552586D0; EP0224494B1; FI864379A0; DK165900C; ES553191A0; AU5661186A; FI864379A; AR241306A1

Abstract

ABSTRACT OF THE DISCLOSURE
Inclusion of salt of non-toxic divalent cation in absorptive pads, e.g., catamenial tampons, inhibits production of toxic shock syndrome toxin-L during use.

Description

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This invention relates to catamenial tampons, suryical and wound dress~ngs and packings, surgical sponges, absorbent materials for sanitary protection, and diapers, hereinafter col-lectively referred to as absorptive pads, and pertains more specifically to such pads effective to su~stantially inhibit in-creased production of toxic shock syndrome toxin-L and other toxic staphylococcal products during use, and to the method of making t such pads.
Absorptive pads comprising a mass of solid water-insol-uble water absorbent material formed into the desired configuration for application to or insertion into a wound or a body cavity and adapted for absorption and retention of body fluids have been used for many years. Cotton fibers and semi-synthetic fibers such as cellulose derivatives including acetate rayon, viscose rayon, polyacrylate rayon, and polyurethane, polyester and other fibers have been widely used in the manufacture of such absorptive pads as well as various non-fibrous water-absorbent materials, parti-cularly cellulose derivatives such as carboxymethyl cellulose, synthetic polymers such as those water-swellable cross-linked poly-mers capable of forming hydrogels, polyurethane sponges, and others.
~; While such absorptive pads provide high capacity absorption and retention characteristics, and hence provide extended periods of protection during use of the absorptive pads, such extended use has increased the time period during which possible bacterial grow-th and production of toxin can occur in the vicinity of the absorptive pad, particularly in the case of catamenial tampons.
Toxic shock syndrome is a severe disease which as been found to be USSN 714,095 - 1 -associated with toxic shock syndrome toxin-L, a staphyloccus~
produced toxin, and has been associated with use of certain brands of tampons, as well as the use of certain nasal and o-ther suryical packings.
It has now been found that certain low concentrations of magnesium ion, below the eoneentration normally present in body fluids such as blood, are critieal for optimal production of toxic shoek syndrome toxie-L and other staphyloeoeeus produets, some of which may be toxic, and it has also been found that various absorptive pad materials have the eapability to absorb or bind magnesium ions.
The present invention provides an absorptive pad, and partieularly a eatamenial tampon, eomprising water-sorptive mater-ial and an amount of non-toxic salt of a divalent cation effeetive to substantially inhibit production of toxic shock syndrome toxin-L and other staphyloeoecal produets during use of said absorptive pad. The invention also provides, in the method of making an absorptive pad whieh eomprises forming a pad from a mass of water-sorptive water insoluble solid material, the improvement whieh eomprises ineluding with said mass of material an amount of non-toxie salt of a divalent eation effeetive to substantially inhibit produetion of toxie shoek syndrome toxin-L or other staphyloeoeeal produets during use of said pad. The invention also provides the msthod of making an absorptive pad eomprising water-sorptive solid material whieh eomprises ineluding with said material a suffieient amount of a non-toxie divalent eation to satisfy the magnesium absorption or binding eapaeity of said mate-rial, and forming said material Lnto said pad - and it provides an g~) absorptive pad, parti.cularly a catamenial tampon, having its magnesium-absorbing or binding capacity satisfied with a non-toxic divalent cation.
Any non-toxic salt can be used provided i-t is sufficient-ly water-soluble to provide the desired ~uantity of divalent cations to saturate the magnesium absorbing or binding capacity of the absorptive pad material - the absorbiny or binding capacity varies widely dependi.ng upon the identity of the particular mate~
rials present in a pad as well as upon the manufacturing procedures followed in each case. In the case of polyacrylate rayon fibers, for example, 1000 micrograms of magnesium acetate or even less per gram of fiber suffices. While any non-toxic salt of a divalent cation can be employed in the absorptive pad of the present in-vention since it will provide ions competing with the magnesium ions naturally present in body fluids and will thus satisfy the absorptive or binding capacity of the pad material for magnesium ions, results are obtained with magnesium salts. In general, an amount of salt effective to inhibit productio.n of toxic shock syndrome toxin-L or other toxic staphylococcal product during the use of an absorptive pad to a level no greater than that normally present in the absence of a p.ad.~.will be sufficient to satisfy the magnesium absorbing or binding capacity of the pad. Suitable salts include those of magnesium, calcium, barium or strontium, the preferred cations, or of other divalent cations such as zinc, manganese, copper, iron, nickel and the like. The anionic portion of the salt is not criticaland may vary widely since very low solubility in water suffices for the purpose of the present inven-tion. Suitable salts include the chlorides, sulfates, nitrates, .. . .

3~

acetates, palmitates, stearates, mandelates, hippurates, and the like, their magnesium salts being preferred. Magnesium stearate and magnesium acetate are particularly preferred.

The salt may be incorporated in the tampon by immersing the completed pad in an aqueous solution or dispersion of the salt, but it is usually more convenient and effective to ~reat one or more of the component materials with the desired salt at some point in the manufacturing procedure before or during incorporation of the material in the pad. For example, in the case of synthetic fiber materials, the fibers can be passed through an aqueous bath containing a suitable salt, or the fibers can be passed through a pair of squeeze rolls to which a supply of said solution is supplied. Magnesium stearate is a preferred salt for application to synthetic fibers because it facilitates processing of the fibers. It is also possible to incorporate the desired salt in a portion only of the pad, for example in the outer wrapper, so that it is in position to be distributed or diffused under condi-tions of use to those other portions of the pad which require satu-ration of their magnesium absorbing or binding capacity. It is ?O preferred, however, that the magnesium absorbing or binding capacity of all components of the pad be satisfied initially, be-fore use of the pad.
An e~cess of salt above the amount required to saturate the magnesium absorbing or binding capacity oE the absorbent material is not harmful, and there is no critical upper limit on the amount of salt employed in order to inhibit production of the toxin.

3~.s() While it is not intended to limit this invention to any particular theor~ or mode of opera-t.ion, it is believed that one or more of the water-sorptive solid materlals normally present in pads such as tampons possesses sufficient absorptive or specific binding capacity for magnesium ions to reduce the concentra-tion of such ions normally present in body fluids to a critical low level at which production of toxic shock syndrome toxin-L and other toxic staphylococcal products is greatly enhanced, and that the present invention operates by eliminating this capacity.

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A catamenial tampon consisting essentially of water-sorptive material having magnesium chelating capability and an amount of non-toxic water-soluble salt of a divalent magnesium ca-tion effective to substantially inhibit production of toxic shock syndrome toxin-1 during use of said tampon.

2. A tampon as claimed in claim 1 in which the amount of said divalent magnesium cation is at least sufficient to satisfy the magnesium-binding capacity of said pad.

3. A tampon as claimed in claim 2 in which said salt is magnesium stearate.

4. A tampon as claimed in claim 2 in which said salt is magnesium acetate.

5. In the method of making a catamenial tampon which compri-ses forming a tampon from a mass of water-sorptive water-insoluble solid material having magnesium-chelating capability, the improve-ment which consists essentially of including with said mass of material an amount of non-toxic water-soluble salt of a divalent magnesium cation effective to substantially inhibit production of toxic shock syndrome toxin-1 during use of said pad.

6. The method as claimed in claim 5 in which the amount of said magnesium cation is at least sufficient to satisfy the magnesium-binding capacity of said tampon.

7. The method as claimed in claim 6 in which said salt is magnesium stearate.

8. The method as claimed in claim 7 in which said salt is magnesium acetate.

9. The method of making a catamenial tampon comprising water-sorptive material having magnesium-chelating capability which con-sists essentially of including with said material an amount of a non-toxic water-soluble salt of magnesium divalent cation sufficient to satisfy the magnesium-binding capacity of said material, and forming said material into a tampon.

10. The method as claimed in claim 9 in which said salt is magnesium acetate.

11. A catamenial tampon consisting essentially of water-sorptive material having magnesium-chelating capability and an amount of non-toxic water-soluble salt of a divalent magnesium cation at least sufficient to satisfy the magnesium binding capacity of said pad.

12. A tampon as claimed in claim 11 in which said salt is magnesium stearate.

13. A tampon as claimed in claim 12 in which said salt is magnesium acetate.